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Trial record 1 of 1 for:    LAPLACE-TIMI 57
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LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy (LAPLACE)

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ClinicalTrials.gov Identifier: NCT01380730
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : October 1, 2015
Last Update Posted : November 15, 2022
Sponsor:
Collaborator:
TIMI Study Group
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.

Condition or disease Intervention/treatment Phase
Hyperlipidemia Biological: Evolocumab Other: Placebo to Evolocumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 631 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects
Actual Study Start Date : July 1, 2011
Actual Primary Completion Date : April 5, 2012
Actual Study Completion Date : April 5, 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
 Other: Placebo to Evolocumab
Administered by subcutaneous injection
Placebo Comparator: Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
 Other: Placebo to Evolocumab
Administered by subcutaneous injection
Experimental: Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Experimental: Evolocumab 105 mg Q2W
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Experimental: Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Experimental: Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Experimental: Evolocumab 350 mg Q4W
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha
Experimental: Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
 Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • AMG 145
  • Repatha


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was measured using ultracentrifugation.


Secondary Outcome Measures :
  1. Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was measured using ultracentrifugation.

  2. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
  3. Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
  4. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
  5. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥ 18 to ≤ 80 years of age
  • On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
  • Fasting LDL-C ≥ 85 mg/dL
  • Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
  • Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%)
  • Uncontrolled hypertension
  • New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
  • Uncontrolled cardiac arrhythmia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380730


Locations
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Sponsors and Collaborators
Amgen
TIMI Study Group
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01380730    
Other Study ID Numbers: 20101155
First Posted: June 27, 2011    Key Record Dates
Results First Posted: October 1, 2015
Last Update Posted: November 15, 2022
Last Verified: November 2022
Keywords provided by Amgen:
Hypercholesterolemia
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Additional relevant MeSH terms:
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Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
Antibodies, Monoclonal
PCSK9 Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs